From our Northumberland facility, we can take your projects from development through to clinical trial manufacture and commercial supply. With the technologies and capacity to manufacture at a wide range of scales, we provide an agile and fully compliant API manufacturing service, specialising in hazardous chemistry.
Our dedicated research and development centre, pilot plant and material sciences centre ensure we can support innovative API development requirements and the scale-up of your projects from small scale to commercial production.
Download our facility spotlight here.
Sterling's Dudley Facility
Opened in 1969
42 acre site
630+ employees
70+ molecules
Approved for schedule 1 to 3 controlled substances
Research and Development Centre
Our dedicated development centre helps you to meet your innovator API development requirements.
Our team of more than 70 skilled scientists provide comprehensive capabilities including:
- cGMP kilo lab facilities at 10, 20, 25 and 50L for clinical and commercial API batches up to ~5kg
- High potency capability at 10 and 20L
- 10 and 20L small scale cGMP hydrogenation equipment
- Full range of supporting analytical services including LCMS, XRPD, ICPMS and NMR
- Validation support services (DoE, QbD)
- 32 fume hoods
- Multi block reactors, process intensification
- World class hazard evaluation laboratory
- Expertise in technology transfer, process development and industrialisation
- Solid State Chemistry team to support solid form development
Our pilot plant ensures we can support the scale-up of your API projects.
Our pilot plant capabilities include:
- Six independent, highly flexible reactor bays
- 200– 1,300 litre scale
- Clinical and commercial API and intermediate capability
- Range of Aurora filters, pressure filters, centrifuges and tray driers
- Biotage chromatographic purification unit
- Controlled substance manufacture
- High containment for charging and offloading potent APIs and problematic materials (e.g. HF/pyridine)
- Temperature capability from -20 to +180°C
- High vacuum WFE / SPE unit and high temperature fractionating unit
Our small molecule API manufacturing facilities offer:
- Broad range of intermediate and API trains
- 1,200 – 13,500 litre scale
- Range of pressure filters, centrifuges and blender driers
- USP purified water system
- Cryogenic capability (-90°C)
- High temperature capability (+200°C)
- High vacuum WFE / SPE unit; fractionating unit – 30 theoretical plates
- Range of milling facilities in cleanroom environment
- Extensive range of capabilities including fluorination, hydroxylamine, organometallic, friedel craft and carbonylation
- Bulk Br2Cl2 H2, ethylene oxide, propylene oxide
Full solid form offerings to align with growing small molecule complexity including:
- Polymorph screening
- Salt selection
- Particle engineering
- Crystallisation scale up
- 3 floors, 2,700 square meters
- 6 ISO class 8 cleanrooms (housing up to 4 discreet milling and micronisation systems)
- Fully equipped analytical laboratory, solid form laboratory, and write up area
- Space for chemistry kilo labs
- Multiple mills to offer customers a range of solutions, including hammer, knife, cone and sieve
Read more about our solid state, and milling and micronisation services.
